Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the efficacy and safety of shr8008 vs. fluconazole in subjects with acute vulvovaginal candidiasis

Conditions: Acute Vulvovaginal Candidiasis

Summary: the purpose of this study is to evaluate the efficacy and safety of shr8008 vs. fluconazole in subjects with acute vulvovaginal candidiasis


Eligibility criteria:
inclusion criteria: 1. females ≥18 and ≤75 years old; 2. clinical diagnosis with vvc episodes at screening, signs and symptoms score of ≥ 7, with a documented positive potassium hydroxide (koh) or gram staining; 3. subjects of childbearing potential must have a negative pregnancy test result at screening and agree to use highly effective contraceptive measures throughout the study; 4. willing to sign the informed consent form to participate in this study. exclusion criteria: 1. have recurrent vulvovaginal candidiasis (rvvc) as defined by 4 or more confirmed vvc episodes in the past 12 months or history of rvvc; 2. presence of concomitant vulvovaginitis caused by other pathogens; 3. history of cervical cancer, or "cervical intraepithelial neoplasia or malignancy" or "atypical squamous cells of undetermined significance (ascus)" as indicated by pap test or other tests reported within 1 year before screening; 4. moderate to severe hepatic and/or renal disorders; 5. have received systemic or vulvovaginal antifungal drugs, antibacterials, antitrichomonal, cyp3a4 substrates or inducers or inhibitors, or vulvovaginal corticosteroids within 7 days prior to randomization; 6. have received any estrogen replacement therapy or vaginal topical products within 7 days prior to randomization; 7. have received systemic corticosteroid therapy within 30 days or systemic immunosuppressant therapy within 90 days prior to randomization; 8. presence of significant laboratory abnormalities at screening; 9. qtc interval greater than 470 ms or other clinically significant ecg abnormalities at screening; 10. have planned surgeries or other medical procedures that may impact compliance with the protocol; 11. known history of hypersensitivity or intolerance to azole antifungal drugs; 12. being in the menstrual period, pregnant, or lactating at screening, or planning to become pregnant during the study period; 13. history of narcotic or drug abuse or alcoholism within 6 months prior to screening; 14. have participated in another clinical study and received the investigational drug containing active ingredient within 30 days prior to screening; 15. other conditions unsuitable for participation in the study per investigator's judgment.
low-dose dexamethasone in newly diagnosed pulmonary sarcoidosis

Conditions: Sarcoidosis

Summary: this trial examines whether low grade suppression of the initial inflammatory process of sarcoidosis by intervention with low-dose dexamethasone therapy achieves significant alleviation of (sub-)acute symptoms, improvement in quality of life, increase in work productivity, and whether this intervention prevents disease progression and reduces total health-care costs.

the orphan disease sarcoidosis causes a major reduction in quality of life and loss of work productivity, especially in young adults. most patients are diagnosed between the age of 20-40 years. in sarcoidosis, multiple organs are affected by inflammation; the cause of the disease is unknown and no curative medication exists. sarcoidosis invalidates the lives of most patient for many years. although curative (pharmaco) therapy is not on hand, immunosuppressive drugs may control the symptoms of the disease. these symptoms are caused by the inflammation in multiple organs, foremost the lungs and the lymphoid system. however, 90% of the sarcoidosis patients receives no immunosuppressive medication at all during the first months after diagnosis, even though the immune system is then highly activated and patients suffer from severe complaints like malaise, fatigue and pain. this wait-and-see policy is common international practice, but scientific grounds and official guidelines are lacking. this project examines whether low grade suppression of the initial inflammatory process of sarcoidosis by intervention with low-dose dexamethasone therapy achieves significant alleviation of (sub-)acute symptoms, improvement in quality of life, increase in work productivity, and whether this intervention prevents disease progression and reduces total health-care costs.

Eligibility criteria:
inclusion criteria: * diagnosis of sarcoidosis, confirmed by histology or cytology * age 18-60 years * no affected organ requiring high dose immunosuppressive therapy * short form - 36 subscale physical functioning score \< 70 points exclusion criteria: * allergy to corticosteroids * diagnosis of glaucoma, osteoporosis, history of fractures * history of gastric ulcera in the past 12 months * current use of non steroidal anti inflammatory drug without co-prescription of proton pump inhibitor * current use of carbamazepin, fenytoin, rifampicin * obesity (bmi \> 30) * pregnancy of lactation
an efficacy and safety study of long-term risperidone microspheres in participants with schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the purpose of this study is to evaluate the long-term efficacy and safety of a long-acting injectable formulation of risperidone (an antipsychotic medication) and its influence on quality of life, in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

this is an open-label (all people know the identity of the intervention) single-arm, and prospective study (study following participants forward in time) of risperidone microspheres in participants with schizophrenia. participants will be treated with intramuscular (into a muscle) injections of either 25 milligram (mg) or 37.5 mg or 50 mg of risperidone twice weekly, every 2 weeks for 2 years. the total duration of study will be 2 years. the efficacy of participants will primarily be evaluated by total positive and negative syndrome scale (panss) score. participants' quality of life and safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participants diagnosed with schizophrenia or schizoaffective disorder (in-patients or out-patients) * participants currently having their symptoms well controlled with a stable dose of oral antipsychotic medication * participants who have signed informed consent form exclusion criteria: * participants who have never received any previous antipsychotic treatment * participants who have received clozapine during the last 3 months * participants with a serious unstable medical condition, including laboratory abnormalities * participants with a history of, or current symptoms of tardive dyskinesia (a complication of neuroleptic therapy involving involuntary movements of facial muscles) or neuroleptic malignant syndrome (a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness) * female participants who are pregnant or breast-feeding, or are of childbearing age without adequate contraception

Keywords: schizophrenia risperidone risperidal consta
comparison of the efficacy of i-prf impregnated collagen and l-prf on healing after impacted third molar surgery

Conditions: Impacted Third Molar Tooth

Summary: impacted third molar extraction is a very common surgical intervention. post-procedure pain causes various post-operative changes such as edema and trismus. minimizing these changes will enable patients to overcome the post-operative process more easily. in this study, it was aimed to compare the possible effects of i-prf (impregnated platelet rich fibrin) type 1 collagen with l-prf (leukocyte platelet rich fibrin) on postoperative complications and wound healing after lower impacted wisdom tooth surgery. there are studies in the literature showing that very different treatment methods are used for buried twenty-year-old surgery. however, although there are studies in which intra-socket l-prf, i-prf, and collagen plugs are applied, there is no accepted standard for comparing the effects of l-prf and i-prf impregnated type-1 collagen with each other or for postoperative comfort. the aim of the study is to observe the effect of 2 different techniques on postoperative complications and possible changes in wound healing and discuss whether there is a difference and the effective one.

fifty patients were included for the randomized, prospective, split mouth and single-blind study. two groups were formed in the study. the lower right and lower left wisdom teeth of the patients with extraction indication for lower impacted wisdom teeth were included in separate groups. in the first group (on one side of the same patients), leukocyte platelet-rich fibrin (l-prf, 2700rpm,12 min) was obtained after lower impacted wisdom tooth surgery, applied into the socket and sutured. the other tooth of the patient was operated 5 weeks after the operation of the region included in the first group. in the second group (to the other side of the same patient), injectable platelet-rich fibrin (i-prf, 700rpm, 3min) was obtained and 1\*2 cm type 1 collagen plug (ace rcp(resorbable collagen plug), resorbable collagen plug, collagen matrix, inc. oakland, new jersey, usa) was impregnated and applied into the socket as such. it was followed for 4 weeks. both surgical sites were sutured with 4\\0 silk sutures (18mm, 3\\8 sharp, 75cm black suture). it was determined randomly which material would be used first on which side.

Eligibility criteria:
inclusion criteria: * individuals aged 18 years and over, * patients with semi-impacted or fully impacted wisdom teeth, * patients without systemic disease (according to asa(the american society of anesthesiologists) classification, asa1 individuals), * individuals who did not use any medication in the last two weeks. exclusion criteria: * individuals with painful temporomandibular joint disease, * internal irregularity and/or inflammatory joint disease with a mouth opening of less than 25 mm, * pregnant and lactating individuals, * individuals who do not come to their postoperative controls, * individuals using different drugs other than those recommended, * individuals who are allergic to the study drugs and materials.
cangrelor prasugrel transition study

Conditions: Coronary Artery Disease

Summary: to demonstrate that patients treated with cangrelor can be directly switched to oral prasugrel and that patients treated with prasugrel can be switched to cangrelor without a significant decrease in the extent of inhibition of platelet aggregation.


Eligibility criteria:
inclusion criteria: 1. greater than / equal to 18 and less than 75 years of age 2. stable coronary artery disease defined by the following criteria 1. previous myocardial infarction defined by admission to the hospital with elevation of markers of injury or the presence of pathologic q waves on at least 2 contiguous electrocardiogram (ecg) leads. or 2. previous revascularization by percutaneous coronary intervention (pci) or coronary artery bypass graft (cabg). and 3. treatment with aspirin (asa) 81 mg daily.

Keywords: cad
a safety, tolerability, pk, and pd study of once weekly isis-fgfr4rx sc in obese patients

Conditions: Obesity

Summary: the purpose of this study is to to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of isis-fgfr4rx.


Eligibility criteria:
inclusion criteria: 1. must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements 2. male or female patients between the age of 18-65 years, inclusive * females: must be post-menopausal (defined as 12 months of spontaneous amenorrhea in females \> 55 years of age or, in females ≤ 55 years, 12 months of spontaneous amenorrhea without an alternative medical cause and fsh levels in the postmenopausal range for the laboratory involved) * males: surgically sterile, abstinent or if engaged in sexual relations with women of childbearing potential, patient is utilizing an acceptable contraceptive method during and for 5 months after the last dose of isis 463588 or placebo (study drug) 3. body mass index (bmi) between 30.0 and 40.0 kg/m2, inclusive 4. patients who are willing to comply with all scheduled visits, treatment plans, laboratory tests and other study procedures 5. agree to abstain from alcoholic beverages for at least 48 hours prior to clinic visits 6. agree to maintain current diet and exercise regimen from screening until end-of-study exclusion criteria: 1. clinically significant abnormalities in medical history (e.g., previous acute coronary syndrome within 6 months of screening, major surgery within 3 months of screening) or physical examination 2. positive test for hiv, hepatitis b or c at screening 3. hypothyroidism or hyperthyroidism 4. weight change \> 5% in the 3 months prior to screening

Keywords: obesity energy expenditure
empathy through pain control: buffered compared to unbuffered 1% lidocaine during iud placement

Conditions: Contraception; Pain, Acute; Anesthesia, Local

Summary: the goal of this research study is to learn more about how different uses of a numbing medication might affect pain levels while getting an iud placed. the investigators are also studying patients' opinions of their clinicians' empathy. the investigators are inviting patients who have never given birth who arrive at their clinic visit seeking an iud. usually, at university of california, san diego (ucsd), for patients who have never delivered, clinicians numb both the sides of the cervix with a lidocaine-based paracervical block. the purpose of this research study is to compare perceptions of pain between buffered (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) vs. unbuffered paracervical block (20 cc 1% lidocaine) during iud placement for nulliparous women.

lidocaine is a drug that has been approved by the food and drug administration (fda). sodium bicarbonate is an additive that buffers the acidity of lidocaine. the combination of the two is safe and effective as a paracervical block for pain relief in various obgyn procedures. at ucsd and other places, it is currently standard practice for people with no prior deliveries to receive a buffered lidocaine paracervical block prior to iud placement. participants who take part in this study, will be randomly assigned to receive an injection of buffered lidocaine or an injection of unbuffered lidocaine to numb the area before iud placement. throughout the local anesthetic and intrauterine device (iud) placement procedure, research team members will question participants about their pain levels, their satisfaction with the procedure, and how much empathy they feel the clinician has shown.

Eligibility criteria:
inclusion criteria: 1. ability to provide informed consent 2. women iud placement for contraception or heavy menstrual bleeding 3. ages 18-50 4. english-speaking 5. participants must not have a past medical history of substance use disorders, pain disorders, use of prescription pain medications or are found to be pregnant 6. nulliparous (never given birth) exclusion criteria: 1. history of ever giving birth 2. current use of prescription pain medication prior to procedure. over-the-counter medications such as those containing ibuprofen, aspirin, acetaminophen, or naproxen are allowed. 3. diagnosed chronic pain condition 4. current pregnancy 5. known allergic reactions to components of the local anesthetic 6. history of an iud placement 7. current substance use or history of substance use 8. known contraindications to iud, such as unexplained vaginal bleeding
perfusion index, prone ,supi̇ne and sitting position

Conditions: Perfusion Index

Summary: the aim was to investigate the effect of anesthesia management on perfusion index changes in obese patients and different anesthesia positions. the effect of positional intra-abdominal pressure and lung-related variables was investigated.

there may be changes in haemodynamic findings in patients after anaesthesia. the most common of these are hypotension and bradycardia. many factors play a role on the hypotensive effect of anaesthesia induction1 . position changes in patients during surgery in obese patients affect these changes.in our study, the changes in haemodimaic findings and the changes in pi and pvi were investigated in patients with bmi 30 and above and in patients with bmi within normal limits after induction of anaesthesia by giving prone position and sitting position.position changes in patients during surgery in obese patients affect these changes. hypertension and hypotension after induction of anaesthesia are common in obese patients. in addition, decreased venous return to the heart due to increased intrathoracic pressure during mechanical ventilation may trigger bradycardia and hypotension.

Eligibility criteria:
inclusion criteria: * 18-70 years range * patients who will be operated in supine prone and sitting positions exclusion criteria: * heart failure * antiarrhythmic drug use hemodynamic instability uncooperative patients

Keywords: perfusion index prone supine anesthesia
a three day trial of azithromycin plus chloroquine for the treatment of uncomplicated plasmodium falciparum malaria

Conditions: Falciparum Malaria

Summary: the treatment of symptomatic, uncomplicated malaria caused by p. falciparum in adults.


Eligibility criteria:
inclusion criteria: * males and females greater then or equal to the age of 18 with uncomplicated, symptomatic malaria as indicated by the presence of blood smears positive for p. falciparum asexual parasitemia between 1000-100,000 parasites/ul and documented fever greater then or equal to 38.5 c/101.3 f rectal or fever greater then or equal to 38 c/100.4 f oral or history of fever as reported by subject within the prior 24 hours. exclusion criteria: * subjects with severe or complicated malaria. pregnant or breast feeding women.
ph 2 bortezomib, dexamethasone, + doxorubicin with alcar for previously treated multiple myeloma

Conditions: Multiple Myeloma

Summary: patients will receive bortezomib, dexamethasone, and doxorubicin in 21 day cycles a total of 4 to 8 times (based on response to the treatment). patients will also receive acetyl-l-carnitine (alcar) daily.

the primary objective of this study is to assess overall response rate to the treatment. secondary objectives include: evaluating and describing the incidence of chemotherapy-induced peripheral neuropathy using the fact/gog-ntx assessment tool; evaluating the utility of adding alcar to the chemotherapy to reduce the incidence of peripheral neuropathy; and evaluating the utility of the grooved pegboard completion time as a longitudinal measure of peripheral neuropathy.

Eligibility criteria:
inclusion criteria: * patients with previously treated multiple myeloma with measurable serum or urine monoclonal protein. exclusion criteria: * patients with previous doxorubicin treatment totaling 220 mg/m2 or more * lvef less than 45% * patients with \>grade ii sensory neuropathy at baseline as assessed by the pi will be excluded * no history of seizures as alcar may lower the seizure threshold * known hiv infection * current pregnancy.

Keywords: previously treated multiple myeloma
the validity and reliability of the upper extremity exercise testing (uulex) in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multiple sclerosis negatively affects the endurance and functionality in the upper extremities. 20 female patients aged 18-70 years who were diagnosed with ms will be included in the study. demographic, family, cigarette alcohol use, etc. information will be obtained from the patients and the study will begin. timed 25-step walking test, upper extremity endurance with uulex, hand-shoulder and arm problems questionnaire (dash) and nine-hole board test (ddtt) evaluation were performed on the patients. manual muscle test for muscle strength, handheld dynamometer handheld grip strength will be measured with a dynamometer and spasticity will be measured with the ashworth scale. depression status of the patients will be determined by the beck depression scale, and the presence of dyspnea will be determined by the dyspnea scale. the validity and reliability of the unsupported upper extremity exercise test (uulex) will be investigated with the obtained data. in order to give the most accurate result of the test in adults over 65 years of age, 3 repetitions will be performed with a resting period of half an hour. limitation of activities of daily living will be evaluated with msqol-54 specific to multiple sclerosis. intraclass correlation coefficient (icc) will be used to determine test-retest reliability.


Eligibility criteria:
inclusion criteria: * diagnosis of multiple scleroisis exclusion criteria: * presence of extreme spasticity in the upper extremities that will prevent the performing of uulex
a comparison of fellow eyes undergoing lasik or prk with a wavefront-guided excimer laser versus a wavefront-optimized excimer laser

Conditions: Hyperopia; Myopia; Astigmatism

Summary: subjects with myopia, hyperopia and astigmatism are being randomized to be treated in one eye with a wavefront-guided excimer laser and their fellow eye treated with a wavefront-optimized excimer laser.

subjects with myopia, hyperopia and astigmatism are being randomized by ocular dominance to be treated with either prk or lasik. one eye will be treated with a wavefront-guided excimer laser and the fellow eye will be treated with a wavefront optimized excimer laser.

Eligibility criteria:
inclusion criteria: * healthy subjects age 21 and older. * subjects with nearsightedness, farsightedness and/or astigmatism. exclusion criteria:autoimmune diseases. * children. * women pregnant or nursing. * ectatic corneal disease. * previous ocular surgery.

Keywords: myopia hyperopia astigmatism prk lasik
a community-based resilience group psychotherapy for only-child loss parents in china

Conditions: Depression

Summary: two communities in changsha was selected, where principle investigators' institution located, to recruit 80 participants into intervention group and control group. resilience therapy group was intervened by a psychotherapy developed by the researchers, which lasts 8 weeks. the themes of each week are start-up, mutual help, trust in yourself, thanksgiving feedback, care for yourself, emotional management, end-up. measurement was conducted before the intervention, immediately after intervention, 3-month after intervention, and 12-month after intervention. a questionnaire was used during each measurement, including several scales in it, including resilience and depression.the saliva test of dehydroepiandrosterone was also done in each measurement.


Eligibility criteria:
inclusion criteria: 1. had only one child but now passed away; 2. failed to have another children; 3. volunteered to participate; 4. the score of resilience was under 72 points indicating a lower or middle level exclusion criteria: 1. in the acute bereavement period (\<6 months); 2. unable to participate in activities due to severe physical illness; 3. receiving drug treatment for mental illness; 4. receiving other psychological therapy